QIAGEN gains access to Cellestis’ early disease detection technology
VENLO, The Netherlands—Using a "scheme of arrangement"—defined as a court-approved agreement between a company and its shareholders or creditors used to execute arbitrary changes in the structure of a business—QIAGEN NV has reached an agreement to acquire Cellestis Ltd. for approximately $355 million in cash, providing QIAGEN with access to a novel "premolecular technology that offers a new dimension in disease detection not currently possible with other diagnostic methods," according to the company's announcement.
The acquisition of Cellestis, a publicly listed, profitable company headquartered in Melbourne, Australia, will provide QIAGEN with exclusive rights to QuantiFERON technology, a proprietary approach for disease detection and monitoring.
Products based on QuantiFERON technology can enhance QIAGEN'S portfolio in DNA-and RNA-based molecular diagnostics in four ways, says Peer Schatz, the company's CEO, citing prevention, profiling, personalized healthcare and point of need as "the four Ps."
Cellestis has successfully commercialized this technology with QuantiFERON-TB Gold In-Tube (QFT), a test for latent tuberculosis, and is in the early stages of commercializing QuantiFERON-CMV for monitoring of disease risk from the life-threatening cytomegalovirus (CMV). These tests are approved and commercialized in various countries and are believed to have significant untapped market potential.
"The potential for the four Ps, which make up our Molecular diagnostics (MDx) portfolio, is very high," says Schatz. "Molecular diagnostics grew 12 percent in 2009 to $4.1 billion. And these growth figures were already low due to the financial crisis. Among the four Ps, personalized healthcare (PHC) is considered to have the greatest potential. Between 1999 and 2009, the overall market for PHC amounted to $13 billion, reflecting a CAGR of 24 percent."
QIAGEN's PHC business is growing at an annual rate of 40 percent, he adds.
QuantiFERON is a patent-protected platform technology that can provide information on diseases far earlier than possible with other diagnostic methods. QuantiFERON tests whole-blood samples for the presence of systemically amplified molecular analytes, which provide information from the immune system's memory. Based on its ability to provide diagnostic information far earlier than DNA-based molecular tests, QuantiFERON is considered a "premolecular" testing technology. As a result, tests based on QuantiFERON can even provide critical information on latent infections, where pathogens (bacteria, viruses, fungi) are present in such low amounts that they are not detectable with traditional DNA-based molecular diagnostics.
QuantiFERON is complementary to QIAGEN's portfolio of molecular diagnostics. Its high sensitivity and ability to provide clinically relevant information means that this technology can be used ahead of DNA- or RNA-based molecular testing. Greater use of QuantiFERON technology can help guide and drive the use of traditional DNA- and RNA-based molecular diagnostics. For example, patients identified through QuantiFERON-based tests to be at risk for certain diseases could then proceed for subsequent testing or increased monitoring with corresponding DNA- or RNA-based molecular diagnostics to assess disease activity levels and guide treatment decisions.
"We believe next-generation DNA- and RNA-based molecular testing can benefit from greater use of QuantiFERON technology, which has a unique ability to identify patients at risk from potentially life-threatening diseases. The power of QuantiFERON can help save lives by enabling medical treatment through earlier, deeper and much more sensitive disease detection than previously possible," says Schatz. "Quantiferon is very a good fit with the QIAGEN portfolio. The products can be ported onto QIAGEN instrumentation, in particular QIAensemble, our automation platform for prevention. Not only TB and CMV, but also other Cellestis products currently under development are complementary with QIAGEN assays. We believe the addition of Cellestis will further strengthen our capabilities to offer innovative sample and assay technologies that are making improvements in life possible."
Since the acquisition is still subject to various approvals, Schatz declines to comment on plans for integrating Cellestis' employees and facilities into QIAGEN's operations.
"Cellestis has succeeded in developing QuantiFERON as a breakthrough technology, via the QFT-TB test that is becoming the standard for latent TB diagnosis," comments CEO Anthony Radford, noting that the test replaces the 110-year-old Tuberculin skin test. "We believe QIAGEN provides the best strategic fit in terms of capabilities and resources. As part of QIAGEN, we will be able to accelerate our growth much faster than as a stand-alone company and offer even greater benefits to patients and healthcare providers."
Following successful completion of the transaction, QIAGEN plans to migrate QuantiFERON onto QIAensemble, a next-generation, high-throughput automation system in development and nearing market entry; QIAsymphony, an automation system for low- to mid-throughput volumes now available around the world; and QIAGEN 's point-of-need testing platforms.
Cellestis has several new products based on QuantiFERON technology under evaluation targeting other diseases and conditions. In the fiscal year ending June 30, 2010, net sales rose 17 percent to $42 million. Profit from operations before tax and non-recurring items in FY2010 was $10.6 million, up 26 percent from FY2009. Its flagship TB test accounts for the majority of current sales.
Cellestis' other commercialized diagnostic product is QuantiFERON-CMV 4, which was launched in 2009 and is the first commercially available test designed to monitor a person's risk of CMV, one of the most common and problematic viral infections in immunosuppressed patients (in cancer, transplantation and HIV therapies).
QIAGEN has DNA-based molecular diagnostic tests for CMV viral load testing that could be complemented by QuantiFERON-CMV to monitor patients for risk of CMV-induced disease.